DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION

Advisory Committee on 

Immunization Practices (ACIP)

Summary Report

August 13, 2014 

Atlanta, Georgia 

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Advisory Committee on Immunization Practices (ACIP) Summary Report August 13, 2014

Table of Contents Page

Agenda 3 

Acronyms 4 

Wednesday: August 13, 2014

Welcome and Introductions 5-6

Pneumococcal Vaccines

 Introduction

 Routine PCV13 Use among Adults Aged >65 Years Old:

 Summary of Evidence, Cost Effectiveness, and GRADE Conclusions

 Introduction

 Routine PCV13 Use among Adults Aged >65 Years Old:

Summary of Evidence, Cost Effectiveness, and GRADE Conclusions

 Considerations for PCV13 Use among Adults and Policy Options

 Recommendations for PCV13 Use among Adults

 Public Comments

 Considerations for PCV13 Use among Adults and Policy Options

7-28

Certification 29

Membership Roster 30

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Final – July 28, 2014 

MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) 

Additional Meeting on Use of Pneumococcal Vaccines in Adults 

Centers for Disease Control and Prevention 

1600 Clifton Road, NE, Atlanta, Georgia 30333 

Roybal Building 24 Room 1103A 

August 13, 2014 

2:00‐4:00 p.m. Eastern Daylight Time (EDT) 

This meeting will be conducted via Webinar and telephone: 

URL: https://www.mymeetings.com/nc/join/

Conference number: PW7936898 

Audience passcode: 5994905 

OR 

Participants can join the event directly at: 

https://www.mymeetings.com/nc/join.php?i=PW7936898&p=5994905&t=c

USA Dial‐in number: 1‐800‐369‐1780 

Participant passcode: 5994905 

AGENDA ITEM PURPOSE PRESIDER/PRESENTER(s)

Wednesday, August 13

2:00 Welcome & Opening Remarks

Dr Jonathan Temte (Chair, ACIP) 

Dr Larry Pickering (Executive Secretary, ACIP, 

CDC) 

2:10 Use of Pneumococcal Vaccines in Adults

• Introduction 

• Routine PCV13 use among adults >65 

years old: summary of evidence, cost‐

effectiveness, and GRADE conclusions 

• Considerations for PCV13 use among 

adults and policy options 

• Recommendations for PCV13 use among 

adults 

• Public comment

Information

& 

Discussion

Dr Nancy Bennett (ACIP, WG Chair) 

Ms Tamara Pilishvili (CDC/NCIRD) 

 

Ms Tamara Pilishvili (CDC/NCIRD) 

Vote Vote Ms Tamara Pilishvili (CDC/NCIRD)

4:00 Adjourn

 

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ACIP 

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Acronyms

AA Accelerated Approval (FDA)

AAFP American Academy of Family Physicians 

ACIP Advisory Committee on Immunization Practices

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

CAP Community-Acquired Pneumonia 

CAPiTA Community-Acquired Pneumonia Immunization Trial in Adults 

CDC Centers for Disease Control and Prevention

CMS Centers for Medicare and Medicaid Services

COI Conflict of Interest 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

FDA Food and Drug Administration

GRADE Grading of Recommendation Assessment, Development and Evaluation 

GSK GlaxoSmithKline

HRSA Health Resources and Services Administration 

IHS Indian Health Service 

IPD Invasive Pneumococcal Disease 

MMWR Morbidity and Mortality Weekly Report

NBP Non-Bacteremic Pneumonia cases 

NIH National Institutes of Health

NVAC National Vaccine Advisory Committee 

NVPO National Vaccine Program Office

PCV Pneumococcal Conjugate Vaccine

QALY Quality Adjusted Life Years

RCT Randomized Controlled Trial

SSUAD Serotype-Specific Urinary Antigen Detection 

VE Vaccine Effectiveness

WG Work Group

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Welcome

Dr. Jonathan Temte 

Chair, ACIP / CDC 

Dr. Larry Pickering

Executive Secretary, ACIP / CDC

Dr. Temte officially called the interim meeting of the Advisory Committee on Immunization 

Practices (ACIP) to order. He welcomed everyone to the teleconference, explained the 

process, and reviewed the agenda.

Dr. Pickering welcomed everyone to the interim meeting of ACIP, the purpose of which was to 

address the use of 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent 

polysaccharide pneumococcal vaccine (PCSD23). He indicated that the proceedings of this 

meeting would be accessible only by phone and web, and that following the presentations there 

would be time for public comment before ACIP voting members took a vote. Slides presented 

during this meeting will be posted on the ACIP website approximately two weeks after the 

meeting concludes, and the meeting minutes will be available on the website within 90 days 

following the meeting. Meeting minutes generally are posted on the ACIP website within 90 

days of the meeting. Members of the press interested in conducting interviews with ACIP 

members were instructed to contact Alison Albert for assistance in arranging these interviews. 

Ms. Albert can be reached at 404-428-6620 or through the Internet at apalbert@cdc.gov. 

Dr. Pickering indicated that the telephone operator managing this meeting would leave 

telephone lines open throughout the entire meeting for the 15 voting ACIP members and 

representatives from the Centers for Medicare and Medicaid Services (CMS), as well as for the 

presenters in the CDC conference room. ACIP members were instructed to mute their phones. 

All others on the call, including ACIP ex officio members, liaison representatives, and members 

of the general audience, were placed in listen-only mode by the operator until Dr. Temte called 

for discussion and public comment. Those wishing to speak were instructed to identify 

themselves before speaking. Dr. Pickering indicated that Dr. Temte would take questions in the 

following order: Voting ACIP members, followed by ex officio members and liaison 

representatives, followed by general audience and members of the public. Ex officio members, 

liaison representatives, and general audience members wishing to speak during the discussion 

period were instructed to signal the operator by pressing *1 on the telephone keypad to be 

placed in the queue.

To summarize conflict of interest provisions applicable to ACIP as noted in the ACIP Policies 

and Procedures manual, Dr. Pickering indicated that members of the ACIP agree to forego 

participation in certain activities related to vaccines during their tenure on the committee. For 

certain other interests that potentially enhance a member’s expertise while serving on the 

committee, limited conflict of interest waivers are issued. Members who conduct vaccine clinical 

trials or who serve on data safety monitoring boards (DSMBs) may present to the committee on 

matters related to those specific vaccines. However, they are prohibited from participating in 

committee votes on issues related to those specific vaccines. Regarding other vaccines of the 

concerned company, a member may participate in a discussion with the proviso that he or she 

Welcome and Introductions

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abstains on all votes related to the vaccines of that company. It is important to note that in each 

meeting, ACIP members declare any conflicts of interest. Dr. Pickering called upon Dr. Temte 

to proceed with the roll call and the request for disclosures of any conflicts of interest from the 

voting ACIP members.

Dr. Temte pointed out that it was relatively unusual to have an interim ACIP meeting such as 

this. ACIP provides advice to the Director of CDC on matters pertaining to use of Food and 

Drug Administration (FDA)-licensed vaccines in the civilian population for control of vaccinepreventable diseases. ACIP is sometimes called to an interim meeting when there is new 

information or pressing issues, which is well within the ACIP charter. He expressed 

appreciation for the incredible efforts of Dr. Pickering, Dr. Jean Smith, Stephanie Thomas, and a 

number of others at CDC who worked diligently during the two previous weeks to plan this 

teleconference. Pertaining to conflict of interest and the roll call, Dr. Temte pointed out that 

when there are votes, it is preferable to reserve abstentions for conflicts of interest. He then 

called the roll, and requested that any conflicts of interest be declared:

ACIP Member

Conflicts of Interest

Dr. Belongia Receives research funding from MedImmune

Dr. Bennett No conflicts

Dr. Bocchini No conflicts

Dr. Campos-Outcalt No conflicts

Dr. Harriman No conflicts

Dr. Harrison No conflicts

Dr. Karron No conflicts

Dr. Kempe No conflicts

Ms. Pellegrini No conflicts

Dr. Reingold No conflicts

Dr. Riley No conflicts

Dr. Romero His institution receives funding from Pfizer and GlaxoSmithKline 

(GSK) for research

Dr. Rubin No conflicts

Dr. Temte No conflicts

Dr. Vázquez No conflicts

The following ex officio members were also confirmed to be present on this teleconference:

Ex Officio Member Affiliation

Drs. Hance and Chin Centers for Medicare and Medicaid (CMS)

Dr. Geibe Department of Defense (DoD)

Dr. Sun Food and Drug Administration (FDA)

Dr. Houston Health Resources and Services Administration (HRSA)

Ms. Groom Indian Health Service (IHS) 

Dr. Kinsinger Department of Veteran’s Affairs (DVA)

Dr. Gorman National Institutes of Health (NIH)

Dr. Gellin National Vaccine Program Office (NVPO)

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Dr. Temte confirmed that a quorum was present, noting that this was the first meeting for Drs. 

Belongia, Riley, and Romero and that further introductions for these new members would be 

made during the October 2014 ACIP meeting.

 

Introduction

Nancy M. Bennett, MD, MS

Pneumococcal Vaccines Work Group Chair

Advisory Committee on Immunization Practices

Dr. Bennett indicated that the focus of this interim meeting was directed toward 

recommendations regarding 13-valent pneumococcal conjugate vaccine. She thanked the 

members of the Pneumococcal Vaccines Work Group (WG) who had been working very hard 

since the June 2014 ACIP meeting to engage in two additional meetings and many long and 

complicated discussions. In addition, she expressed gratitude to Ms. Tamara Pilishvili for her 

dedication and hard work since June to support the WG in being able to bring these 

recommendations forward during this interim meeting.

She reminded everyone that the terms of reference for the Pneumococcal Vaccines WG are to:

 Review current data on efficacy, effectiveness, immunogenicity, and cost-effectiveness of 

pneumococcal vaccines

 Review current recommendations considering up-to-date evidence, including 

epidemiological studies conducted post-licensure, and assess strength of the evidence

 Revise or update recommendations for pneumococcal vaccine use, as needed

The specific focus of this interim session was to address routine immunization with PCV13 for 

adults 65 years of age and older and to propose language for a vote. 

As a reminder, PCV13 was licensed for use among adults 50 years of age and older on 

December 30, 2012. The FDA approved this use under the Accelerated Approval (AA) pathway

based on non-inferior immunogenicity compared to PPSV23. The indications are for prevention 

of pneumococcal disease, including pneumonia and invasive disease, in adults 50 years of age 

and older; and prevention of disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 

6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. A post-approval condition of licensure included 

the conduct of a randomized controlled trial (RCT) of PCV13 against pneumococcal pneumonia 

among adults >65 years old in the Netherlands, which is known as the Community-Acquired 

Pneumonia Immunization Trial in Adults (CAPiTA). 

Use of Pneumococcal Vaccines in Adults

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To summarize the discussions from the June 2014 ACIP meeting, evidence was reviewed that 

included the CAPiTA study results; indirect (herd) effects of PCV13 use in children; and costeffectiveness and public health impact of different adult pneumococcal vaccination strategies. 

During that meeting, the WG received recommendations from the committee to consider various 

factors pertaining to selecting the optimal strategy; the decreasing utility in a setting of 

increasing herd effects; and a variety of inputs in the sensitivity analysis of the costeffectiveness model presented in June 2014. The WG completed all of this work since June 

2014 and eventually narrowed down to one strategy, which was that PCV13 be used in 

combination with PPSV23. Thus, the objectives for this interim meeting were to present a 

specific policy option and to ask the committee to vote. 

Given that this has been a matter of concern for the WG as well as other ACIP members for 

quite some time, Dr. Bennett reviewed the reasons the WG felt that an accelerated timeline was 

appropriate. One reason decision-making about recommendations was deferred in 2012 was to 

await results of the CAPiTA study, the results of which are now available, and also to have the 

most current information on herd effects. Another reason is that the WG is interested in 

providing the benefits of PCV13 to older adults and recognizes that these benefits are likely to 

be greatest in the short-term. It has been almost three years since vaccine licensure, so the 

WG felt that it was important to move quickly toward making a recommendation now that the 

results of CAPiTA are available, and no additional evidence is anticipated in the near future that 

would affect ACIP’s decision. Thus, there was no reason to extend the timeline to await 

additional data. The WG also viewed this as an opportunity to afford the greatest population 

benefit of an optimal vaccination strategy against pneumococcal disease that would include 

PCV13 and PPSV23. Finally, it is not likely that the process of full implementation will occur 

until ACIP makes the recommendation. Therefore, the WG felt that it was important to move 

forward as expeditiously as possible toward ACIP making a recommendation.

The proposed recommendation the WG presented during this session included the following

language: 

Adults >65 years of age with no previous pneumococcal vaccine (PCV13 or PPSV23) 

Proposed language:

Adults 65 years of age or older who have not previously received pneumococcal vaccine 

or whose previous vaccination history is unknown should receive a dose of PCV13 first 

followed by a dose of PPSV23

PCV13-naïve adults >65 years of age previously vaccinated with PPSV23

Proposed language:

Adults 65 years of age or older who have not previously received PCV13 and who have 

previously received one or more doses of PPSV23 should receive a dose of PCV13.

Potential time-limited utility of routine PCV13 use among adults >65 years

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Proposed language:

The recommendations for routine PCV13 use among adults >65 years old* should be reevaluated in 2018 and revised as needed. 

*if recommended by ACIP and approved by CDC Director

Dr. Bennett pointed out that the WG was proposing this simple language for the 

recommendation with the expectation that recommendations about intervals will appear in the 

guidance that accompanies these recommendations.

 

Routine PCV13 Use among Adults Aged >65 Years Old:

Summary of Evidence, Cost Effectiveness, and GRADE Conclusions

Tamara Pilishvili, MPH

Respiratory Diseases Branch, 

National Center for Immunizations and Respiratory Diseases

Centers for Disease Control and Prevention

Ms. Pilishvili thanked Dr. Bennett for leading the WG through these very complex discussions 

over the past year or so. During this session, Ms. Pilishvili reviewed a summary of evidence 

supporting routine PCV13 use among adults >65 years of age and Grading of Recommendation 

Assessment, Development and Evaluation (GRADE) conclusions. These data have been 

presented extensively to the committee over the past couple of years when the vaccine was 

licensed and again during the June 2014 ACIP meeting. The GRADE review and conclusions 

were also revised and presented to the committee, and the details of evidence reviewed through 

GRADE were in the background materials shared with the committee prior to this interim 

meeting. Therefore, only a brief summary was presented during this session. Ms. Pilishvili also 

summarized the discussion the WG had on sequential use of PCV13 and PPSV23 in terms of 

intervals and rationale for selecting those intervals. In addition, she reiterated the issues 

pertaining to the indirect effects and long-term utility of routine PCV13 use among adults and 

presented the proposed language for a vote.

 

To summarize the evidence the WG has reviewed supporting PCV13 use among adults >65 

years of age, the results of the long-awaited CAPiTA trial were presented to ACIP during the 

June 2014 meeting. The results of the trail showed that PCV13 prevents IPD and nonbacteremic pneumonia among adults1

. This trial demonstrated efficacy of 75% against vaccinetype invasive pneumococcal disease (IPD), as well as a 45% reduction in vaccine type nonbacteremic pneumonia. In addition, the WG reviewed a large body of evidence through 

immunogenicity studies that showed that the immune response is non-inferior or improved for 

some serotypes for PCV13 or PCV7 versus PPSV232,3. The safety of PCV13 was 

demonstrated in clinical trials, and results show that the vaccine is safe for use among adults. 

The WG presented the GRADE evaluation and conclusion to the committee that demonstrated 

that a type 2 quality of evidence supports the use of this vaccine among adults 65 years of age 

or older [

1

CAPITA, June 2014 ACIP; 2Phase III trials, Pfizer, ACIP 2011, 2012; 2DeRoux et al. 

CID 2008, Goldblatt et al 2009].

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Recent data demonstrate that vaccine-preventable disease burden remains among adults 65 

years of age and older. In 2013, an estimated 2600 vaccine-type cases of IPD occurred.1

 In 

one year, an estimated 50,000 cases of vaccine-type inpatient community-acquired pneumonia

(CAP) occurred.2 In the short-term, PCV13 likely provides adequate coverage of disease 

causing serotypes. Approximately 20% to 25% of IPD is caused by PCV13 types1 based on 

2013 data, and approximately 10% of all CAP cases may be caused by PCV13 types.

2 The last 

estimate is based on studies using a serotype-specific urinary antigen detection (SSUAD) test, 

which is the same test that was applied in the CAPiTA Trial [

1

Active Bacterial Core Surveillance, 

2013; 2 Estimate based on studies using serotype-specific urine antigen test, Pfizer].

The WG considered various strategies for PCV13 use among adults, including vaccination at 

ages 50, 60, and 65 years; using PCV13 instead of PPSV23; and using PCV13 in sequence

with PPSV23. Consideration was given to the expected public health impact and costeffectiveness of these various strategies. After the two meetings, the WG concluded that 

adding PCV13 at age 65 years to existing PPSV23 recommendations is likely to be the optimal 

strategy. This is based on the expected health benefits for all outcomes assessed, as well as 

cost-effectiveness that is comparable to other adult interventions accepted as cost-effective

under the base case assumption.

The results of the analysis assessing expected public health impact of adding PCV13 at age 65 

to existing polysaccharide vaccine recommendations are shown in the following table:

Health Outcomes Change in Outcome Compared to 

Existing PPSV23 Recommendation

IPD -226

Inpatient NBP -4,961

Outpatient NBP -7,252

Deaths (IPD) -33

Deaths (NBP) -332

QALYs 3,053

Life-years 4,627

This base case analysis was shared with the committee during the June 2014 meeting. Ms. 

Pilishvili reiterated that she was not presenting the methodology again. Briefly, this model 

estimates the public health impact for one cohort of 65 year olds who were followed through 

their lifetime and compares the new strategy of adding PCV13 at age 65 to existing PPSV 

recommendations, which was the comparison used for all of the analyses presented. According 

to the results presented in June 2014 pertaining to this base case assumption, health benefits 

are expected for all of the outcomes evaluated. For example, over 200 cases of IPD, around 

5000 cases of in-patient NBP cases (NBP), and over 7000 cases of outpatient NBP cases are 

expected to be averted.

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In terms of the cost-effectiveness of adding a dose of PCV13 at age 65 years to PPSV23 for the 

same model, for the base case assumptions, it was estimated that the cost per quality adjusted

life years (QALY) gained for this strategy is approximately $62,000 and over $40,000 per lifeyear gained. These estimates fall within the range of the interventions that are accepted as 

cost-effective [Stoecker, ACIP June 2014].

Following the June 2014 meeting, the WG received several suggestions on the inputs for the 

cost-effectiveness and public health impact analyses for the model that was presented. 

Sensitivity analyses were conducted for some of these inputs, including shorter duration of 

protection for PCV13 against IPD and NBP, PPSV23 efficacy against NBP, and CMS price for 

vaccine doses. 

For the sensitivity analysis varying the input of the waning of PCV13 protection against IPD and 

NBP, the assumption was no change in the efficacy during the 5 years post-vaccination based 

on the results of the CAPiTA trial that showed no measurable decline in efficacy for the duration 

of the trial. Following that a linear decline to 0% efficacy over a period of 20 years was 

assumed. The results of the sensitivity analysis varying the input for waning of PCV13 

protection are presented in the following table:

When the input for the waning for PCV13 was varied, the number of cases averted for all of the 

outcomes was reduced, but a large change was not observed for all of the outcomes. The costs 

per QALY gained increased from $62,000 for base case to over $65,000, and cost per life-year 

gained increased from $40,000 to over $43,000. However, no qualitative changes were 

observed in the results by varying these inputs.

An additional sensitivity analysis was performed for the input of efficacy of PPSV23 against

NBP. To reiterate, zero efficacy against NBP was used for the base case analysis. The WG 

reviewed the available literature and published studies showing the efficacy of this vaccine 

against NBP. In particular, this was focused on the meta-analysis that was conducted in 2008 

that showed a 73% efficacy against of PPSV1 against NBP. However, four of the five studies 

that were used for that endpoint were conducted with a previous formulation of the 

polysaccharide vaccine, and only one of the five studies utilized the current formulation of the 

23-valent vaccine. That particular study showed no efficacy against NBP2

. In addition, the later 

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meta-analysis conducted also showed no efficacy against NBP3. A recent study reported 64% 

efficacy against NBP in an RCT conducted among long-term care residents4

, and another 

reported 48% efficacy in a large cohort study5

.[1Moberly et al 2008; 2Ortquist et al; 3Huss et al 

2009; 4

Muruyama et al 2010; 5Ochoa-Gondar et al 2014] 

 

The WG reviewed both of these studies, and there were questions about the limited 

generalizability of the findings of the study in long-term care residents, methodological concerns

related to the proportion of disease that was bacteremic from the cases that were used as the 

endpoint for the analysis for both studies, and questions about the analytic methods. Therefore, 

the WG decided not to alter the base case assumptions for this input. However, they did 

conduct a sensitivity analysis evaluating 45% efficacy for PPSV23 against NBP, equivalent to 

the efficacy input for the conjugate vaccine. The results of this sensitivity analysis are 

presented in the following table:

As expected, there was a reduction in the number of pneumonia cases expected to be averted 

assuming an efficacy of 45%, which is equivalent to the efficacy of PCV13. The cost per QALY 

gained increased from over $62,000 to over $300,000 and the cost of life-year gained increased 

from over $40,000 to over $190,000.

In addition, the WG considered using a different source for cost of vaccine dose as 

recommended. Given that the population of adults 65 years of age and older are Medicareeligible, the WG used the CMS prices instead of CDC contract prices in the sensitivity analysis. 

The prices per dose by source are shown on the following table:

 

Vaccine CDC Cost/ Dose CMS price (95%AWP)**

PPSV23 $44.50 $ 78.00 

PCV13 $89.75 $154.00 

The CMS prices represent 95% of the average wholesale price. These are the prices that are 

annually reported and are being set as a maximum reimbursement price for each vaccine by 

CMS. The inputs in the last column were used in the sensitivity analysis. In consultation with 

the CDC’s lead Health Economist, the decision was made to use CMS price for the sensitivity 

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analysis only: because the analysis was done from the societal perspective, costs were 

intended to reflect the value of resources used to produce intervention; whereas, the CMS figure 

represents reimbursements, which are not likely the resource value. The results of this

sensitivity analysis are presented in the following table:

CDC Cost/ Dose

(base case)

CMS price (95%AWP)**

(sensitivity analysis)

Cost/QALY 62,065 110,284

Cost/Life-year saved 40,949 72,763

In this analysis, the cost per QALY changed from over $62,000 to over $110,000 and the cost 

per life-year saved change from over $40,000 to over $72,000.

To summarize the evidence that the WG reviewed pertaining to the sequence and intervals for 

PCV13 and PPSV23, the studies reviewed showed that immune response is improved when 

PCV13 given as the first dose1,2. No studies were designed to evaluate the length of an optimal 

interval between PCV13 and PPSV23. Various intervals have been utilized in studies including 

2, 6, or 12 months and 3-4 years1,2,3,4. These individual intervals were assessed in separate 

studies. The conclusion that the WG drew from this evidence was that there is an improved 

immune response compared to baseline for the various intervals evaluated. Comparing the 

sequence of PCV13 followed by polysaccharide vaccine to the baseline, there was an improved 

response seen for all intervals. In addition, there was a non-inferior response following 

administration of PCV followed by PPSV23 versus PCV alone observed for all intervals. 

However, it is difficult to make comparisons across all studies since each used only one interval. 

There was one study with direct comparison of the 2-month interval in a series of PCV followed 

by PPSV versus a 6-month interval, which found that the immune response was equivalent 

between the 2-month and 6-month interval groups. However, the study did reveal increased 

reactogenicity with a 2-month interval4

 [1Phase III studies (004, 3005, 3010), February 2011 

ACIP; 2

DeRoux et al. CID 2008; 3Goldblatt et al. CID 2009; 4Myernik et al. CID 2008]. 

The WG’s considerations for selection of intervals included immune response and safety. In 

addition, as the WG discussed intervals for PCV followed by PPSV, they were mindful of the 

fact that by extending this interval, the risk window for the serotypes unique to the 

polysaccharide vaccine might also be increased. Therefore, for that interval there will be no 

protection provided by the additional serotypes that are included only in the polysaccharide 

vaccine. The WG also took into consideration practical aspects such as timing for the next visit, 

and programmatic considerations such as quality measures and immunization systems.

The WG concluded that PCV13 should be given first when possible. In terms of the interval 

between PCV13 followed by PPSV23, the WG felt that 6 to 12 months would be appropriate. 

The interval for PCV13 when given post-PPSV23 for adults who previously received a 

polysaccharide vaccine for either an age-based or risk-based indication should be one year or 

longer. In addition, the WG felt that it is important to include flexibility in the guidance to 

providers if doses cannot be administered within the recommended window. For example, 

language could be included in the guidance to state that, “If a second dose cannot be given 

during this time-window, a dose can be given later during the next visit.” 

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Indirect effects and the long-term utility of PCV13 have been the subject of a lot of WG 

discussion. The WG has presented several times to this committee on the indirect effects of 

PCV7 introduction in the pediatric population on PCV7-type IPD and pneumonia among adults 

of all age groups, showing that dramatic effects have been observed among adults of all age 

groups. In addition, the WG shared the most recent data with ACIP on indirect impact provided 

by 3 years of PCV13 use among children. PCV13 indirect effects have further reduced the 

proportion of adult IPD caused by PCV13 types and the pneumonia disease burden. If the 

impact post-PCV13 is similar to what was observed after introduction of the 7-valent vaccine, 

additional reductions in vaccine-type disease burden among adults are likely in the next 3 to 5 

years. However, given the fact that PCV13 uptake was much more rapid than for PCV7, 

because of PCV7 shortages observed soon after licensing, the largest impact post-PCV13 may 

have already been observed due to this rapid PCV13 uptake. Nevertheless, the key point is 

that the expected benefits of PCV13 use among adults will likely decline over time with 

continued use of PCV13 among children. 

The WG estimated cases potentially preventable annually among adults 65 years of age and 

older, which is reflected in the following table:

Ms. Pilishvili reiterated that this table does not present the cumulative impact anticipated over 

the timeframe presented here, but rather shows cases potentially preventable for each year 

presented. It was estimated that in 2015, if a 20% additional reduction due to herd effect and 

coverage of 10% (with a range of 5% to 30%) were presumed, the estimated 160 IPD cases 

are vaccine preventable, and over 2000 cases of inpatient CAP, and nearly 3000 cases of 

outpatient CAP. Moving to 2019, based on the post-PCV7 experience, an 86% reduction due to 

herd effects occurred between 2003 and 2009. From 2013 to 2019, if the same 86% reduction 

due to herd effects is observed, and coverage improves to 30%, the number of preventable 

cases would be lower in 2019.

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To summarize the WG conclusion on PCV13 use for adults 65 years of age and older, in the 

short-term, a recommendation for universal PCV13 use is warranted. In the long-term, 

continued herd effects may limit the utility of a universal recommendation. The magnitude of 

indirect effects is unknown, and there is uncertainty around the burden of vaccine preventable 

non-bacteremic pneumonia. There is an opportunity to prevent disease during the 2014-2015 

respiratory disease season. 

Considerations for PCV13 Use among Adults and Policy Options

Tamara Pilishvili, MPH

Respiratory Diseases Branch, 

National Center for Immunizations and Respiratory Diseases

Centers for Disease Control and Prevention

Ms. Pilishvili highlighted the categories of adults under consideration for PCV13 use, as well as 

policy options. A recommendation is already in place for adults with immunocompromising 

conditions. For this discussion and the recommendation language, adults who previously 

received PCV13 for one of the indications based on the 2012 ACIP recommendations were not 

considered. The discussion and language shared with ACIP focused on adults who have not 

received PCV13 previously. Within this group are adults who are naïve to polysaccharide 

vaccine, as well as those who would have received a dose or more of the polysaccharide 

vaccine for an age-based or risk-based indication.

The proposed recommendation the WG presented during this session included the following 

language:

Adults >65 years of age with no previous pneumococcal vaccine (PCV13 or PPSV23) 

Proposed language:

Adults 65 years of age or older who have not previously received pneumococcal vaccine 

or whose previous vaccination history is unknown should receive a dose of PCV13 first

followed by a dose of PPSV23

Adults >65 years of age with no previous pneumococcal vaccine (PCV13 or PPSV23)

Proposed guidance on intervals for sequential use:

A dose of PPSV23 should be given 6 to 12 months following a dose of PCV13. If 

PPSV23 cannot be given during this time window, a dose of PPSV23 should be given 

during the next visit. The two vaccines should not be co-administered.

PCV13 (@ 65 years or later) + PPSV23

 6-12 months

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PCV13-naïve adults >65 years of age previously vaccinated with PPSV23

Proposed language:

Adults 65 years of age or older who have not previously received PCV13 and who have 

previously received one or more doses of PPSV23 should receive a dose of PCV13.

PCV13-naïve adults >65 years of age previously vaccinated with PPSV23

Proposed guidance on intervals for sequential use:

A dose of PCV13 should be given at least 1 year after the receipt of the most recent 

PPSV23 dose. For those for whom an additional dose of PPSV23 is indicated, such 

dose should be given 6 to 12 months after PCV13 and at least 5 years since the most 

recent dose of PPSV23. 

1) PPSV23 + PCV13

(@ 65 years or later)

>1 years

 >5 years

2) PPSV23 + PCV13 + PPSV23

 (< 65 years old) (@ 65 years or later) (@ 65 years or later) 

 >1 years >5 years

Potential time-limited utility of routine PCV13 use among adults >65 years

Proposed language:

The recommendations for routine PCV13 use among adults >65 years old* should be reevaluated in 2018 and revised as needed. 

*if recommended by ACIP and approved by CDC Director

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The WG felt that it would be important to continue to monitor the impact of the new 

recommendation in the target population of adults >65 years in terms of vaccine uptake of 

PCV13 and PPSV23, PCV13-type IPD burden and serotype distribution for IPD cases, and 

PCV13-type and all CAP burden. Continued monitoring of disease trends among PCV13-naïve 

adults is needed to evaluate the impact of herd effects and the long-term utility of routine PCV13 

use among adults in terms of PCV13-type IPD burden and serotype distribution for IPD cases 

among unvaccinated, and changes in PCV13-type CAP burden among individuals younger than 

65 years. ACIP should be routinely updated on the changes in the vaccine-preventable disease 

burden among adults due to PCV13 direct and indirect effects during the next 3 years. These 

data should inform revisions as needed to the proposed adult PCV13 recommendations in 

2018. Declining burden of PCV13-type disease among adults <65 years old due to indirect 

effect of vaccinating children may signal that PCV13 is no longer needed. Revised costeffectiveness evaluation incorporating changes in disease burden, uptake, and the cost of the 

vaccines will help align this recommendation with other adult vaccines in use. 

Discussion Points

Dr. Harrison recalled that one of the issues discussed during the last ACIP meeting focused on 

whether both vaccines would be covered by Medicare, but some of the background materials 

implied that they would not be covered until 2016. He wondered how that might impact 

implementation of the program.

Ms. Pilishvili asked the CMS liaisons to respond to this question.

Dr. Chin (CMS) envisioned two situations where this potentially could be influenced from a 

Medicare standpoint. In the short-term, there would probably be less of an impact for those who 

are recommended to receive a vaccine but have not previously received one under Medicare. 

Mostly this will impact those who have received a prior vaccination, which is likely to be the 23-

valent vaccine. Currently, the CMS coverage policy is that one vaccination is permitted for all 

adults under Medicare. There are instances in which some individuals who are at the highest 

risk may receive a second vaccine under Medicare. That is specifically defined in the CMS 

regulations, but is not a general practice. In the immediate timeframe, it would be unlikely for 

those who have received a prior vaccine to receive a second vaccine. This would mainly apply 

to this coming season. In order for CMS to modify the coverage policy, any recommended 

changes from ACIP and the supporting evidence would have to be reviewed. There are policy 

mechanisms available if CMS decides to proceed with a change in coverage to allow a 2-

vaccine regimen. However, Dr. Chin was not certain which mechanism would be the most 

appropriate for this type of change. There will have to be a discussion with CMS’s General 

Council. Based on past experience, when there is a substantial change in a recommendation or 

coverage policy, CMS’s typical approach is to use a mechanism that allows for public comment. 

This is typically in the form of a rule or regulation through Rulemaking. Typically, Rulemaking is 

entered into at the beginning of the year with a Proposed Rule usually by the summer and a 

Final Rule in November, which would be effective the following January. If CMS were to 

undergo a change, it would likely be a year before a second dose would be available for those 

who have been previously vaccinated. Approval of the recommendation in the fall would 

probably be the best timeframe in order to overlap the doses in the next cycle. That would be a 

year and a half for those individuals who would want a second vaccine. Depending upon the 

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recommendation from the committee, there is a mechanism and an opportunity for CMS to 

modify the coverage policy.

Dr. Harrison wondered about implications for someone who receives the first vaccine at age 65 

but is turned down for the second vaccine.

Dr. Chin (CMS) responded that there is no mechanism for that scenario if such an individual 

wanted to get the second vaccine this year. If there is a change in ACIP’s recommendation, 

they can address this during the next cycle. Some people will be able to get the vaccine 

immediately, but they could possibly get the following year if CMS makes changes.

Dr. Temte requested clarification regarding whether this meant that coverage of the cost of the 

vaccine and the administration fee would be denied for a Medicare recipient.

Dr. Chin (CMS) replied that currently, if an individual has received a vaccine under Medicare 

Part B, the second vaccine and administration fee would not typically be covered unless the 

individual is in the highest-risk group.

Dr. Campos-Outcalt inquired as to whether there was any chance that this vaccine could be 

made a Part D vaccine rather than Part B.

Dr. Chin (CMS) indicated that many vaccines that are not covered under Part B are perhaps 

covered under Part D. However, since CMS has a very specific section that covers 

pneumococcal vaccine under Part B, that is where the benefit is currently and it is unlikely to 

cross two programs.

Dr. Kempe said she is not concerned that someone would be denied for a year. However, she 

is concerned about the risk window for the PPSV23-only serotypes if this is a prolonged 

process. She asked about the chance that this could be a three-year process, or perhaps not 

occur at all.

Dr. Chin (CMS) replied that this would be based on the evidence and the recommendation. 

From the initial review, evidence supported by an RCT is very strong and CMS would like to see 

a publication from that. In addition to evidence supported by an RCT, a change in the 

recommendation would also be helpful. In that sense, if benefit is clearly demonstrated for the 

Medicare population, that benefit would drive CMS’s decisions and would be a major factor in 

CMS making changes in the policy to improve the health of the population. From a preliminary 

read, this would meet those criteria. It would be unlikely that no change would be made, based 

on the evidence. In terms of how long it would take, the optimal timeframe would be the typical 

12-month timeframe.

Ms. Pellegrini thought this was an incredibly important question, not because it should affect the 

actual science of the recommendation, but because it is going to have tremendous bearing on 

implementation from a practical perspective in terms of uptake and whether people are going to 

be able to afford to have this vaccine. She was troubled that as a group, ACIP was feeling a 

great deal of urgency to the extent of having an interim meeting, but it did not seem that CMS 

shared that sense of urgency based on a minimum of a one-year lag. She realized the 

challenge since this vaccine is in the statute and is under a different standard, but she asked the 

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CMS representatives whether the agency might consider issuing an interim Final Rule in 

January, February, or March that would allow the recommendation to go into effect and 

coverage to begin but still have public comment and later refinement of the Rule.

Dr. Chin (CMS) said that while it was a good suggestion, he could not immediately respond. 

However, he said he would present it to their director to determine the feasibility of an interim 

Final Rule.

Dr. Reingold said that he did not quite understand the financial aspect in terms of whether 

Congressional approval would be required for the extra expenditure.

Dr. Chin (CMS) responded that typically with coverage decisions, the costs for most services 

are not directly calculated in the manner mentioned. In rare instances, costs enter the equation, 

but not specifically for immunization. Those services are basically always described in statutes. 

This is not one of them.

Dr. Temte said he thought that of the 44 million Americans 65 years of age and older, roughly 

65% have already received PPSV23, and that about 2 million Americans enter Medicare per 

year, which is approximately 170,000 to 180,000 per month.

Dr. Chin (CMS) confirmed this to be correct, noting that the Medicare population also includes 

the disabled, which adds about 8 million. The total number is roughly 50 million in the Medicare 

population, with roughly 42% to 44% being older adults. Enrollment is usually 1.5 to 2 million, 

but the “Baby Boomers” are starting to age into the population. Looking at the demographics, 

the peak will be up to 4 million individuals each year.

Dr. Campos-Outcalt requested clarification that if this recommendation is made sometime this 

fall, it is likely not to be implemented until January 2016. People were saying about a year from 

now, but that really would not be the case. It would be closer to 15 to 16 months. He clarified 

that he asked the question about Part D instead of Part B because he was not familiar with the 

statute on pneumococcal vaccine in terms of whether it is specific to a particular vaccine, or if it 

is general to disease or a bacteria. In the past, some vaccines have been put into Part D rather 

than Part B because of consideration of this formula that calculates the payment reduction to 

physicians when costs exceed a certain amount—not that it has ever been implemented. There 

has been an attempt to fix this, but in the past, the cost of vaccines has been a consideration. 

That does not count when they go into Part D.

Dr. Chin (CMS) confirmed that with CMS’s typical mechanism to make changes, that 

assumption would be correct. If they proceed rapidly in drafting the Rule and Regulation, it 

would be effective in January 2016. In terms of Part D versus Part B, Dr. Chin said he was not 

familiar with the way Part D prices are decided. There is a mechanism for Part D policies as 

well. The statute for pneumococcal vaccine is Part B and is not specific. It basically is for a 

pneumococcal vaccination, and does not specify any particular formulation. When a vaccine is 

in a program, it usually stays in that program.

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Dr. Schuchat indicated that usually when ACIP makes a recommendation, there is a lag before 

insurance coverage picks it up regardless of whether it is public or private insurance. It turns 

out that the pneumococcal conjugate 13-valent vaccine would immediately be covered for 

Medicare beneficiaries under Part B for those who have not had a previous vaccine or who have 

unknown prior vaccine status. Unlike the usual recommendations that are not required by 

private insurance until the calendar year following publication in the Morbidity and Mortality 

Weekly Report (MMWR), Medicare Part B uptake of a first dose of the 13-valent conjugate 

vaccine could be taken up immediately. The timing of the Medicare process is unclear. It could 

take a few different paths to implement a second dose regardless of whether it was a 

polysaccharide following a conjugate or vice versa. The WG suggested an interval that could 

be 6 to 12 months in terms of the guidance with some flexibility. To clarify the road that ACIP 

would be taking with some sense of urgency about what could happen this fall, a first dose of 

conjugate vaccine for unvaccinated people or those with unknown status would have no delay in 

Medicare Part B uptake because of how the statute is written. Following an ACIP vote, 

Medicare authorities can review the evidence, look at the process, and sort out how quickly or 

slowly the sequential subsequent dose language could catch up with ACIP so that there is no 

delay for the first dose. That was why ACIP was being convened for a vote during this interim 

meeting, given the 5000 cases of CAP that might be prevented if there is 10% uptake of a 

vaccine this year.

Dr. Temte added that basically it would apply to 15 million Americans over 65 years of age 

receiving Medicare benefits who have not yet received a pneumococcal vaccination. 

Unfortunately, many of those are either people who refuse, who are in situations where the 

vaccine has not been offered, or who have problems with access to care. Still, there remains a 

large group of individuals to whom this could apply immediately. The last figure he saw for 

“Baby Boomers” reaching age 65 was about 170,000 per month.

Dr. Harriman thought that CMS must know, based on their own records, whether someone has 

been vaccinated previously. In theory, someone with an unknown history could be rejected for 

vaccine coverage.

Dr. Chin (CMS) responded that it would be difficult to say how many would be rejected, if any at 

all, in that situation. The recommendation was written based on a clinical recommendation, so 

he did not know what was in place regarding the coding system.

Dr. Harriman requested clarification for the rationale for not using the CMS price for the vaccine 

in the analysis, and whether this is what is done when costing other vaccines in similar 

analyses.

Ms. Pilishvili requested that Dr. Stoecker respond as one of the Health Economists who was 

consulted about how the analysis should be done.

Dr. Stoecker (Tulane University) did not want to use CMS reimbursement rates as the cost, 

because these are reimbursements and do not necessarily reflect the resources expended to 

produce the vaccine. Some of this is a possible transfer payment to other parties. When taking 

a societal perspective, it is important to talk about the production costs of the vaccine. This is 

what is done with other vaccines. In general, they do not want to use transfer payments, which 

are payments made from one party to another that do not necessarily reflect a creation of value.

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Dr. Reingold thought that for the polysaccharide, the recommendation was that people should 

receive a second dose 5 years after the first dose, or that at least some individuals should get a 

second dose. It was not clear whether that was covered under Part B or was relevant, but it 

seemed to him that at this point, CMS already covers some second doses of the pneumococcal 

vaccine. Regarding monitoring the impact of introducing the conjugate vaccine into the over 65 

population, he was in favor of what was laid out on slide 27. It was not clear to him how they 

would disentangle the data about the indirect effects of vaccinating children versus the direct 

effects of vaccination the older population. He cautioned against implying with this slide that at 

some time in the future they would able to disentangle that, unless someone could explain to 

him how that would be done.

Dr. Chin (CMS) replied that basically the revaccination in Medicare is for the group of highest 

risk patients. Those who are immunocompromised can get a second vaccination after 5 years. 

That is a small group.

Ms. Pilishvili added that the WG discussed, and everyone agreed, that it will be challenging to 

disentangle direct and indirect effects, and what was presented on slide 27 was just a general 

approach to monitor impact of age-based recommendation focused on adults 65 years of age 

and older. There will not be routine use of PCV13 in younger adults. Monitoring for disease 

among younger adults will offer some indication of the contribution of herd effects. She agreed 

that this would not be a clear-cut understanding of the contribution of direct versus indirect 

effects. They did not mean this slide to be a final proposal for a defined study that would allow 

for the disentanglement of herd effects from direct effects. She agreed with Dr. Reingold’s 

comment that it will be challenging to disentangle those two effects.

Dr. Bennett agreed that this will be very complicated, but there is potential to assess the rates of 

disease in vaccinated people versus unvaccinated people, particularly in the EIP sites. It will 

not be easy, but if they can collect vaccination rates and good data on the cases that occur for 

IPD and NBP, they may be able to make inferences.

An inquiry was posed regarding whether the issue related to the indirect effect of vaccinating 

older people with PCV13 and figuring out that contribution versus the indirect effects of children 

receiving PCV13. Large differences in vaccine coverage during the first couple of years may 

help, but the issue concerns whether there will be large differences.

Dr. Bennett did not think there was a good answer for that.

Dr. Karron inquired about the timeline for reassessment and the choice of 2018 as the time to 

do that. This is the most expensive vaccine in the armamentarium, and it should be used as 

long as necessary to provide protection, but it probably should not be used beyond that time 

period if the benefits are found to have decreased significantly. She wondered whether some 

assessments should be done earlier than that, recognizing that they are difficult. Regarding the 

interval between PCV and PPSV, she understood that they were not being asked to vote on 

recommendations related to that interval and that it would be in the guidance, but it seemed 

from the data presented that there is not a lot of data on exactly what that interval should be. 

Given some of the programmatic considerations, she wondered whether there might be some 

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thought given to specifying a minimum interval and then allowing beyond that. For example, not 

less than two months or whatever that might be, rather than 6 to 12 months.

Ms. Pilishvili replied that 2018 was the date that the WG projected based on expected herd 

effects post-PCV7 in terms of when maximum herd effect would be expected to be observed. 

Potentially, that is a good time to re-evaluate the recommendation. She agreed with Dr. Karron 

that some studies should monitor the trends over this period of time. This should not be a onetime assessment and it can be done on a continuous basis. The WG did propose that the ACIP 

continuously be updated on the direct and indirect impact of the new recommendations. 

Regarding the 6 to 12 month interval, the WG did not have perfect evidence to allow them to 

say that one interval is better than another. Therefore, the practical consideration was weighted 

toward that 6 to 12 month interval based on comments received from healthcare providers on 

the WG who felt that a practical time when a patient would present for a second visit would be 

within that window of 6 to 12 months. At the same time, everyone on the WG felt that it would 

be important to allow flexibility so that providers do not interpret the 6 to 12 month interval as the 

only possibility for giving a subsequent dose. The WG started approaching the guidance in 

terms of minimum intervals similar to what is recommended for immunocompromised adults, 

which is worded as “8 weeks or greater.” However, there was concern among the WG that this 

approach does not provide good guidance to providers, so they wanted a more defined interval 

than “8 weeks or longer.” From a programmatic and provider perspective for immunization 

services and quality measures, the WG members felt that it would be useful to provide a more 

defined interval in the primary language.

Dr. Belongia noted that he was somewhat hesitant to speak up, since he is new to ACIP and 

does not have all of the history that other members have. He said he had reviewed the videos 

of the meeting, gone over the slides, and read a lot of the original references. He expressed 

concern that this analysis may be rushed and may not be sufficiently robust to support a change 

in national policy. The WG did a tremendous job given their timeframe, but due to the 

complexity of the issue, it seemed impossible to fully understand all of the implications in less 

than two months. Three issues in particular concerned him in terms of the impact on burden of 

illness and cost analysis versus the CAPiTA study itself. The entire analysis essentially hinges 

on the assumption that 10% of all CAP is due to vaccine-type pneumococcal disease. That 

assumption is based on 4 studies, 3 of which are unpublished and all of which use the 

proprietary Pfizer diagnostic urine test to identify vaccine-type cases of pneumococcal disease. 

Second, the results from those studies, which are using highly validated cases of confirmed 

pneumonia, are extrapolated to incidence rates that are based merely on ICD codes, which Dr. 

Belongia was positive have a substantially lower predictive value compared to a research-based 

case definition for pneumonia. Third, the assumption in the base case of vaccine efficacy of 

PPSV23 against pneumococcal pneumonia was zero. He acknowledged that the sensitivity 

analyses were conducted using 45%, but in that analysis everything else was held at the base 

level. Some lessons were learned from the influenza vaccine in terms of the dangers of relying 

on non-specific outcomes to estimate the impact of an intervention, but it seemed that this 

analysis was doing that. At this point, he did not feel that there was enough evidence to make 

that judgment.

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Dr. Bennett agreed that there are a lot of questions about moving forward with this. The 

weaknesses that Dr. Belongia pointed out in the data are not likely to be resolved in a timely 

manner. These are profound issues with respect to the knowledge of pneumonia, and they 

have been issues with pneumococcal vaccine for the last 25 to 30 years. She agreed that the 

data are not perfect, and the analysis is therefore not perfect. However, in the context of the 

last 25 to 30 years, they are moving toward better knowledge, but it will not be immediate. The 

WG concluded that the longer they wait, they less they afford people over the age of 65 

protection from pneumococcal disease. It is not clear when these questions will be answered in 

a satisfactory way, and the WG feels that there will not be helpful information forthcoming.

Dr. Belongia appreciated these comments, noting that data were also reported for hospitalized 

NBP, which should be a much more specific type of outcome than taking all-cause pneumonia. 

Similarly in the outpatient setting, it is a wild guess as to what proportion of ICD-coded 

pneumonia actually represents pneumococcal pneumonia. He thought it would be possible to 

perform additional analyses to assess some inputs like IPD and hospitalized NBP and then use 

some sensitivity analyses assuming different vaccine-type proportions to determine whether 

these findings are robust, and whether this is the best intervention compared to all of the 

possible interventions that the WG considered, but with a range of scenarios.

Referring to slide 3 from the CAPiTA trial showing 45% efficacy of PCV13 in prevention of NBP, 

Dr. Temte noted that the study was conducted in the Netherlands, where he did not believe they 

use a PPSV23 or equivalent vaccine in the elderly, and the patients recruited for the study were 

all pneumococcal-vaccine naïve. He thought that this approach maximized the benefit. He 

wondered whether this was considered by the WG or in the cost-effectiveness analysis.

Ms. Pilishvili confirmed that PPSV is not routinely recommended in the Netherlands and is not 

being used. This was a placebo-controlled trial in adults who were naïve to the polysaccharide 

vaccine. This was accounted for in the GRADE review of the evidence. The comparison of 

interest for the GRADE review was comparing PCV to the current standard of care, 

polysaccharide vaccine; whereas, the trial compared it to placebo. Therefore, the evidence was 

downgraded for not having the correct comparison group when extrapolating CAPiTA results. 

The overall conclusion was that there is still strong type 2 evidence.

Dr. Campos-Outcalt thought the 4th bullet in slide 3 was worded incorrectly, as type 2 or level 2 

evidence is moderate, not strong. He was not sure where the term “strong” came from and he 

did not believe it was in the methodology. The categories are: High, Moderate, Low, and Very 

Low. Level 2 is “moderate,” and he thought the slide needed to be corrected. He wondered 

what was known about this vaccine and co-administration in this age group, particularly 

regarding adverse reactions and the benefits of this vaccine and others that might be coadministered (e.g., zoster vaccine, Tdap, and influenza). In childhood vaccines, this is one of 

the things that is tested.

Dr. Temte inquired as to what extent doses of pneumococcal vaccine are coupled with influenza 

vaccination for those 65 years of age and older in this country. A lot of clinics, his included, will 

have standing orders for both pneumococcal and influenza vaccine during the season when 

influenza immunization is administered. Standing orders tend to work very well.

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Dr. Schuchat responded that the number was not readily available, but they can get it in the 

future. As a reminder, in the CAPiTA study, many of the individuals in the placebo and

pneumococcal conjugate arm received influenza vaccine with their investigational vaccine. 

Quite a bit of adult immunization occurs in conjunction with influenza vaccination, so it is not 

unlikely that a lot of polysaccharide doses given to people 65 and over would be given with 

annual influenza vaccine.

Dr. Bennett emphasized that one of the reasons the WG is eager to move forward with this 

recommendation is the hope that PCV13 will be given as the first dose with influenza vaccine. 

She indicated that many of the people in CAPiTA received both vaccines.

Dr. Campos-Outcalt emphasized that this was entirely different from actually studying the 

efficacy question, so the effect of co-administration of influenza and pneumococcal vaccine on 

either is not known.

Dr. Bennett said that she did not believe that the efficacy of influenza vaccine was studied at the 

same time.

Dr. Schuchat reminded everyone that for those 65 years and older, the Tdap recommendation is 

based on fairly indirect information. The 13-valent vaccine is now being considered based on a 

randomized placebo-controlled trial in 85,000 people. Much of the vaccine is being coadministered with influenza vaccine, so it is likely to mimic the performance of the vaccine when 

given with influenza. CDC can check with the company about the data they have developed, if 

there are data, about immunogenicity results for PCV13 given at the same time as other adult 

vaccines. She said she was not personally familiar with the literature on PPSV23 coadministered with other vaccines, so CDC can look into this. Again, the CAPiTA results would 

be mimicking influenza and PCV13 co-administration with clinical protection data.

Dr. Campos-Outcalt said it seemed like they should be providing some guidance on this 

question, and it stood out that they were not saying anything about this even though they do for 

most other vaccines.

Ms. Pilishvili replied that they could review more details of the data and include it in the 

guidance for the language of co-administration of this vaccine with other vaccines. She 

reminded everyone that when the immunogenicity data were presented to ACIP initially, data on 

co-administration with influenza vaccination were also shared. The bottom line conclusions 

were that non-inferiority was demonstrated by applying the statistical tests when PCV was coadministered with influenza vaccine versus separately. But, a lower response was observed for 

some serotypes. However, she cautioned that the WG did not recommend this vaccine based 

on immunogenicity data before the CAPiTA trial results were available because the correlate of 

protection among adults was not understood. In other words, when more antibody response 

was seen for some serotypes with co-administration with the influenza vaccine, there was no 

way of translating that into clinical protection.

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Given the perceived urgency and the fact that the CAPiTA findings are very important, Dr. 

Belongia wondered whether anyone had considered the possibility of issuing an interim 

guidance that PCV13 may be used in lieu of PPSV23 in people over 65, and that ACIP will issue 

more comprehensive recommendations in 2015 regarding the use of those two vaccines. That 

approach would buy some more time to carefully consider the issues.

Dr. Bennett responded that the WG briefly discussed an interim recommendation, but they were 

not confident that they would have a pathway to a more firm recommendation than is already 

available. Also, there was concern about implementation. As discussed earlier, Medicare 

moving forward with coverage for two pneumococcal vaccines depends upon ACIP making a 

recommendation, and the WG felt that it was important to move forward.

Regarding the spacing of PCV13 after PPSV23, Dr. Campos-Outcalt wondered what was 

known about the optimal interval and what it was based on. Two-thirds of people over 65 have 

had PPSV23 and now are recommended to receive a PCV13, although they probably will not 

receive it for a year to a year and a half.

As with the interval of PCV13 followed by PPSV23, Ms. Pilishvili indicated that no studies have 

assessed the optimal waiting interval for adults who have previously received polysaccharide 

vaccine to receive the conjugate vaccine. The interval was based on all studies that are 

available in terms of intervals that have been evaluated. She reminded the committee that this 

evidence was reviewed previously, and a similar recommendation was made for 

immunocompromised adults stating that waiting one year or longer was optimal for following the 

polysaccharide vaccine with the conjugate vaccine. Again, the data are also limited for that 

interval.

Referring to slide 23 regarding the optimal sequence of 6 to 12 months following a dose of 

PCV13, Dr. Campos-Outcalt wondered if less than 6 months would be acceptable. That is, is 

there a minimum time that has to pass?

Ms. Pilishvili reiterated that minimum time was incorporated in the initial language. However, 

the WG did not like the open-ended “8 weeks or later,” but certainly a minimum interval could be 

indicated for providers in the guidance language. Intervals as short as 8 weeks have been 

evaluated with an adequate immune response. The study she shared that assessed a 2-month 

versus 6-month interval showed that immunogenicity was somewhat higher with the 2-month or 

8-week interval. 

Dr. Campos-Outcalt suggested revising the language to say “no earlier than 2 months,” because 

stating the minimal interval is important.

Ms. Pilishvili emphasized that the WG discussed this and felt that including the interval in the 

recommendation wording might be problematic. The way minimum intervals are usually 

interpreted, if a vaccine is given at an interval sooner than 8 weeks, the adult dose is invalidated 

and repeat vaccination is recommended. There are no data to show that if the vaccine is given 

2 days before the 8-week minimum interval that it should be repeated, or that there is any value 

or potential harm in repeating that dose. Therefore, the WG tried to avoid having the 8-week 

minimum interval defined in the guidance. That was one of the reasons the WG preferred not to 

include a minimum interval in the language.

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Dr. Kempe said her impression was that the 2-month interval was not optimal because of 

increased reactogenicity.

Ms. Pilishvili confirmed that the WG discarded a 2-month or 8-week interval because of the one 

study that showed increased reactogenicity. However, specifying anything other than 8 weeks 

as a minimum was avoided for the reasons outlined earlier.

Dr. Bennett referred to slide 15 showing considerations for the selection of intervals. One of the 

reasons the WG elected to include the intervals in the guidance rather than the recommendation

was in order to refine the language about the intervals.

Dr. Doskey (AHIP) inquired as to whether CDC had ensured vaccine supply from the 

manufacturer if the recommendation was extended as proposed.

Ms. Pilishvili called upon the manufacturers to comment. She reminded everyone that the 

manufacturers commented on this during the June 2014 ACIP meeting, when they indicated 

that they anticipated that a sufficient supply is available if this recommendation is made. Dr. 

Schuchat confirmed that Pfizer publicly commented during the June meeting that they anticipate 

supply in all projections, and that this should not be a constraint.

Dr. Temte asked Dr. Doskey if he had any idea how many people over the age of 65 have coinsurance through which vaccine would be covered. In his practice, those are the people who 

easily get zoster coverage.

Dr. Doskey (AHIP) said that while he did not readily have the information, he could find out.

Dr. Loehr (AAFP) indicated that there are already people who will be handled under the normal 

policy of PPSV23 who would have protection. He expressed concern as a practicing family 

physician, as he has a 67-year old in his office who already had PPSV23 two years ago, and he 

cannot tell this individual whether Medicare will pay for PCV13. The vaccine costs $135/dose, 

which is a sizeable concern, and this patient probably will not get the vaccine because of the 

cost. He was pleased that the Pneumococcal WG included a sunset evaluation. Based on 

other vaccine recommendations, the implication is that 6 to 12 months will be interpreted as a 

minimum interval even if there are indications elsewhere in the guidance.

 

Dr. Moore (AIM) expressed her desire to determine how the immunization program can best 

support clinicians implementing this recommendation for the Medicare population. Her concern 

is that implementation will be extremely limited because of the hesitation to administer 

something for which they might not be reimbursed. She thought that PCV13 was already 

covered under Medicare Part B, because CMS pays for a single dose of pneumococcal vaccine 

regardless of the formulation. The vote during this session would make explicit ACIP’s 

recommendation that the one dose should be PCV13 for those who have zero or unknown 

doses administered since enrolling in Medicare, which is 1 in 3 Medicare patients. The ACIPrecommended second dose would be administered if and when CMS changes its regulations to 

permit reimbursement for a second dose, and the earliest estimated date for that would be 

January 2016. If this is needed to make this happen, she supported moving forward so that the 

CMS process could get underway. She inquired as to whether there was any estimate of the 

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risk that the CMS change would not happen, or that the second dose coverage effective date 

could be delayed well beyond early January 2016, and whether this would pose any risk for 

those who received the PCV13 vaccine first and then had an open-ended time for getting the 

second dose.

Dr. Schuchat confirmed that Dr. Moore’s understanding of the Medicare coverage already in 

effect was correct. She invited Medicare experts to comment on the probability of delays; 

however, she did not believe they would be able to predict what would unfold over the years 

ahead. There is a Medicare process to update the guidance based on recommendations.

Dr. Kempe reminded everyone that Dr. Chin did comment on this earlier, and indicated that 

while he could not guarantee it, he thought that the January 2016 date could be assumed. She 

was also concerned with whether there was a reasonable chance this would occur, but she felt 

reassured by Dr. Chin’s response.

Dr. Temte noted that the meeting was nearing the end of its allotted timeframe, and he inquired 

as to whether anyone was willing to make a motion.

Dr. Bennett made a motion that ACIP vote to recommend PCV13 for adults over the age of 65, 

and that the WG anticipated a vote on the combined package.

Dr. Temte requested that the slides with the proposed language be shown again (slides 30, 31, 

32), and reminded everyone that no direct comments would be made on the intervals in the 

recommendation, but would be included in the guidance based on discussions during a number 

of ACIP meetings and review by the WG.

 

Dr. Reingold suggested inserting a comma after word “first” on slide 30.

Dr. Rubin seconded the motion.

Dr. Temte called for any additional and/or public comments.

Regarding the language of the proposed recommendation, Dr. Jodar (Pfizer) indicated that 

Pfizer is concerned about the specific mention of a date of 2018. Evaluating the effectiveness 

of the vaccine and the herd protective effects on a regular basis is warranted; however, stating a 

specific date is problematic considering the low immunization rate and the difficulty of increasing 

uptake. He wondered whether the WG was concerned that healthcare professionals might wait 

until 2018. It would be unprecedented for ACIP to specify a date, especially since constant 

evaluation of effectiveness and herd protection is being done on regular basis.

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Bob Blancato (NANASP) indicated that he was present during the June 2014 ACIP, and he 

wanted to repeat some points. The National Association of Nutrition and Aging Service 

Programs (NANASP) serves older people daily with means in homes and community centers 

and strongly associates themselves with comments on use of pneumococcal vaccines, 

especially older adults. NANASP is concerned that too few people are taking advantage of this 

vaccine, and is sensitive to the issue about Medicare and hopes that ACIP’s vote will expedite 

activity on the part of Medicare for expanding coverage. NANASP’s concern is very basic. If 

someone comes to their program and has influenza, it can spread rapidly and create major 

problems in NANASP’s daily operations. On behalf of older people served on a daily basis, 

NANASP applauds ACIP’s efforts and hopes the vote comes out in a way that supports broader 

use of this vaccine.

Virginia Ladd (AARDA) reiterated her comments from earlier in the summer on behalf of the 

American Autoimmune Related Diseases Association (AARDA), which represents 50 million 

Americans with autoimmune disease, many of whom have been compromised either by therapy 

or by disease. She emphasized that herd immunity is an important factor for this population 

because they are compromised or are taking immunocompromising therapy.

Alice Knapp (Pasco County Health Department) indicated that she did not have a question, but

requested that Slide 30 be shown again.

Dr. Mel Kohn (Merck) ensured that the committee was aware that there may be some limitations 

on manufacturers’ ability to discuss this kind of sequential vaccination. These intervals are not 

aligned with what is on the label for either vaccine and might represent an off-label

recommendation. He wondered if FDA might want to comment on that. Many issues around 

implementation were raised during this meeting, and he expressed personal concern about 

them. They should assess the completion of series of vaccines outside of the pediatric 

population. Unfortunately, the track record as a nation was not encouraging in that regard. 

Therefore, he was concerned that people would get one vaccine and not the other. He wanted 

to make sure that point was clearly called out for ACIP to consider.

Dr. Sun (FDA) said that the labels make no reference to the other vaccine, so he did not think 

this would necessarily preclude an ACIP recommendation for sequential use of the two 

products. Further, because no claims are made within labels about other competitors’ vaccines, 

he did not see this as a problem. 

Dr. Temte read slides 30, 31, and 32 reflecting the full recommendation for which the motion 

was made to ensure that everyone was clear about the motion.

Dr. Campos-Outcalt requested further clarifications about Dr. Temte’s earlier comments 

regarding abstentions, as he was unaware of any particular rules that would prevent this. 

Dr. Temte replied that there are no rules for abstentions; however, traditionally there has been 

an effort to minimize abstentions and make “yes” or “no” votes. Abstentions are typically used 

in situations where there is a conflict of interest. Based on the ACIP charter and other rules of 

order, there are no direct limitations. 

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Vote: Use of Pneumococcal Vaccines in Adults 65 Years of Age and Older

Dr. Bennett made a motion to accept the three components of the recommendation for use of 

pneumococcal vaccines in adults > 65 years of age as a package as proposed. Dr. Rubin 

seconded the motion. The motion carried with 13 affirmative votes, 2 negative votes, and 0 

abstentions. The disposition of the vote was as follows:

13 Favored: Bennett, Bocchini, Harriman, Harrison, Karron, Kempe, Pellegrini, Romero, 

Reingold, Riley, Rubin, Temte, and Vazquez

 2 Opposed: Belongia and Campos-Outcalt

 0 Abstained: N/A

 

Dr. Bennett thanked everyone, acknowledging that this was a huge amount to ask from CDC 

staff and ACIP members. The WG is very grateful for everyone’s hard work, and for allowing 

this meeting to occur.

Dr. Temte expressed appreciation for all of the efforts from CDC staff and Dr. Pickering for 

helping to organize and operationalize a meeting, which is difficult over the phone and through 

web mediums with over 500 people attending. He also expressed appreciation for the liaisons 

and ACIP members who took a large amount of time out of the day for this.

 

Dr. Pickering reported that ultimately, 1142 participants were on the teleconference. This vote 

was very important and interesting for everyone, and he expressed his hope that the majority of 

people would be happy. He thanked everyone, emphasizing that this was a combined effort by 

a lot of high quality people. 

In conclusion, Dr. Temte said he still felt very strongly that this is a large problem in terms of a 

vaccine-preventable disease, especially the older adult population. Regardless of the vaccine 

being used, this vaccine is still greatly underutilized not only for adults over 65 years of age, but 

also for younger adults with ongoing medical indications. This at least provides a signal that 

ACIP takes seriously the issue of health care and prevention in older adults, and at least strives 

to do the best they can for this population. He thanked everyone for their time and attention and 

wished them a very good rest of the day.

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Upon reviewing the foregoing version of the August 13, 2014 ACIP meeting minutes, Dr. 

Jonathan Temte, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.

Certification

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CHAIR

TEMTE, Jonathan L., MD, PhD

Professor of Family Medicine

University of Wisconsin School of Medicine and Public Health 

Madison, WI 

Term: 07/01/2011-06/30/2015

EXECUTIVE SECRETARY

PICKERING, Larry K., MD

Senior Advisor to the Director

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Atlanta, GA

MEMBERS

BENNETT, Nancy, MD, MS

Professor of Medicine and Community and Preventive Medicine

University of Rochester School of Medicine and Dentistry

Rochester, NY 

Term: 07/01/2011-06/30/2015

BELONGIA, Edward, MD 

Director 

Center for Clinical Epidemiology & Population Health 

Marshfield Clinic Research Foundation 

Marshfield, WI 

Term: 07/01/2014-06/30/2018

BOCCHINI, Joseph A., Jr., MD

Professor and Chairman

Department of Pediatrics

Louisiana State University Health Sciences Center

Shreveport, LA

Term: 07/01/2011-06/30/2015

CAMPOS-OUTCALT, Douglas, MD, MPA

Chair

Department of Family, Community and Preventive Medicine

University of Arizona College of Medicine - Phoenix

Phoenix, AZ 

Term: 07/01/2011-06/30/2015

ACIP Membership Roster

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HARRIMAN, Kathleen, PhD, MPH, RN

Chief, Vaccine Preventable Disease Epidemiology Section

Immunization Branch

California Department of Public Health

Richmond, CA

Term: 07/01/2012 – 06/30/2016

HARRISON, Lee H., MD 

Professor of Medicine and Epidemiology

Infectious Diseases Epidemiology Research Unit 

University of Pittsburgh

Pittsburgh, PA

Term: 07/01/2012 – 06/30/2016

KARRON, Ruth A., MD

Professor and Director

Center for Immunization Research 

Department of International Health

Johns Hopkins Bloomberg School of Public Health 

Baltimore, MD

Term: 07/01/2012 – 06/30/2016

KEMPE, Allison, MD, MPH

Professor of Pediatrics

Director of Primary Care Fellowship

University of Colorado School of Medicine

Director of Research

Division of General Academic Pediatrics

Director of Children’s Outcomes Research Program

The Children’s Hospital of Denver

Denver, CO

Term: 07/01/2013 - 06/30/2017

PELLEGRINI, Cynthia

Senior Vice President

Public Policy and Government Affairs

March of Dimes

Washington, DC

Term: 07/01/2013-06/30/2017

REINGOLD, Arthur L., MD

Professor of Epidemiology

Edward Penhoet Distinguished for Global Health and Infectious Disease

Associate Dean for Research

School of Public Health

University of California

Berkeley, CA

Term: 07/01/2013-06/30/2017

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RILEY, Laura E., MD 

Associate Professor, Obstetrics, Gynecology and Reproductive Medicine 

Harvard Medical School 

Maternal Fetal Medicine 

Massachusetts General Hospital 

Boston, MA 

Term: 07/01/2014-06/30/2018

ROMERO, José R., MD, FAAP 

Professor of Pediatrics 

Horace C. Cabe Endowed Chair in Infectious Diseases 

Director, Pediatric Infectious Diseases Section University of Arkansas for Medical 

Sciences and Arkansas Children's Hospital 

Director, Clinical Trials Research 

Arkansas Children's Hospital Research Institute 

Little Rock, AR 

Term: 07/01/2014-06/30/2018

RUBIN, Lorry, MD

Director 

Pediatric Infectious Diseases

Steven and Alexandra Cohen Children’s Medical Center of New York

North Shore-Long Island Jewish Health System

New Hyde Park, NY

Professor of Pediatrics, Hofstra-North Shore LIJ School of Medicine

Hempstead, NY

Term: 07/01/2012 – 06/30/2016

VÁZQUEZ, Marietta, MD

Associate Professor of Pediatrics

Department of Pediatrics

Yale University School of Medicine

New Haven, CT

Term: 07/01/2011-06/30/2015

EX OFFICIO MEMBERS

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth

Senior Policy Advisor

Division of Quality, Evaluations and Health Outcomes

Children and Adults Health Programs Group

Center for Medicaid, CHIP and Survey & Certification

Centers for Medicare and Medicaid Services

Baltimore, MD

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Department of Defense (DoD)

GEIBE, Jesse, MD, MPH, MBA

CDR, Medical Corps 

Defense Department Liaison Officer

Centers for Disease Control and Prevention

Atlanta, GA

Department of Veterans Affairs (DVA)

KINSINGER, Linda S., MD, MPH

Chief Consultant for Preventive Medicine

Office of Patient Care Services

National Center for Health Promotion and Disease Prevention

Durham, North Carolina

Food and Drug Administration (FDA) 

SUN, Wellington, MD

Director, Division of Vaccines and Related Product Applications

Office of Vaccines Research and Review

Food and Drug Administration

Rockville, MD 

Health Resources and Services Administration (HRSA)

HOUSTON, A. Melissa, MD, MPH, FAAP 

Chief Medical Officer 

Division of Vaccine Injury Compensation 

Health Resources and Services Administration 

Rockville, MD

Indian Health Service (IHS)

GROOM, Amy, MPH

Immunization Program Manager

Indian Health Service

Albuquerque, NM

National Vaccine Program Office (NVPO)

GELLIN, Bruce, MD, MPH

Director

National Vaccine Program Office

Department of HHS, Public Health and Science

Washington, DC

National Institutes of Health (NIH)

GORMAN, Richard L., MD

Associate Director for Clinical Research

Division of Microbiology and Infectious Diseases/NIAID

National Institute of Health

Bethesda, MD

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LIAISON REPRESENTATIVES

American Academy of Family Physicians (AAFP)

LOEHR, Jamie, MD, FAAFP

Cayuga Family Medicine (Owner)

Ithaca, NY 

American Academy of Pediatrics (AAP)

BYINGTON, Carrie L., MD 

H.A. and Edna Benning Presidential Professor of Pediatrics 

Associate Vice President for Faculty and Academic Affairs 

University of Utah Health Sciences Center 

Salt Lake City, UT

American Academy of Pediatrics (AAP)

Red Book Editor 

KIMBERLIN, David, MD

Professor of Pediatrics

Division of Pediatric Infectious Diseases

The University of Alabama at Birmingham School of Medicine

Birmingham, AL

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs

American Academy of Physician Assistants

Alexandria, VA

American College Health Association (ACHA)

EVEN, Susan, MD

Executive Director

Student Health Center

University of Missouri

Columbia, MO

American College of Obstetricians and Gynecologists (ACOG)

AULT, Kevin A., MD 

Professor and Division Director, General Obstetrics and Gynecology 

Department of Obstetrics and Gynecology 

Kansas City, KS

American College of Physicians (ACP)

FRYHOFER, Sandra Adamson., MD, MACP

Adjunct Associate Professor of Medicine

Emory University School of Medicine

Atlanta, GA

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American College of Physicians (ACP) (alternate)

POLAND, Gregory A., MD

Mary Lowell Professor of Medicine and Infectious Diseases

Mayo Clinic 

Rochester, MN

American Geriatrics Society (AGS)

SCHMADER, Kenneth, MD

Professor of Medicine-Geriatrics

Geriatrics Division Chief

Duke University and Durham VA Medical Centers

Durham, NC

America’s Health Insurance Plans (AHIP)

NETOSKIE, Mark J., MD, MBA, FAAP

Market Medical Executive, CIGNA 

Houston, TX

American Medical Association (AMA)

FRYHOFER, Sandra Adamson., MD, MACP

Adjunct Associate Professor of Medicine

Emory University School of Medicine

Atlanta, GA

American Nurses Association (ANA)

BREWER, Katie, MSN, RN

Assistant Director

Patient Care Services

Fairfax County Government

Fairfax, VA

American Nurses Association (ANA) (alternate)

HAYES, Carol E., CNM, MN, MPH

Advanced Practice Nurse

American Nurses Association

American College of Nurse Midwives

DeKalb Board of Health

Decatur, GA

American Osteopathic Association (AOA)

GROGG, Stanley E., DO, FACOP

Associate Dean/Professor of Pediatrics

Oklahoma State University-Center for Health Sciences

Tulsa, OK

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American Pharmacists Association (APhA)

FOSTER, Stephan L., PharMD, FAPhA

Professor and Vice Chair, Department of Clinical Pharmacy

University of Tennessee Health Sciences Center, College of Pharmacy

Memphis, TN

Association of Immunization Managers (AIM)

MOORE, Kelly, MD, MPH 

Medical Director, State Immunization Program

Tennessee Department of Health

Nashville, TN

Association for Prevention Teaching and Research (APTR)

McKINNEY, W. Paul, MD

Professor and Associate Dean

University of Louisville School of Public Health and Information Sciences

Louisville, KY

Association of State and Territorial Health Officials (ASTHO)

DWELLE, Terry L, MD, MPHTM, FAAP, CPH

State Health Officer

North Dakota Department of Health

Bismarck, ND

Biotechnology Industry Organization (BIO)

LEWIN, Clement, PhD, MBA

Head, Medical Affairs and Immunization Policy

Novartis Vaccines and Diagnostics

Cambridge, MA

Council of State and Territorial Epidemiologists (CSTE)

HAHN, Christine, MD

State Epidemiologist

Office of Epidemiology, Food Protection and Immunization

Idaho Department of Health and Welfare

Boise, ID

Canadian National Advisory Committee on Immunization (NACI)

GEMMILL, Ian MacDonald, MD, CCFP, FCFP, FRCP(C) 

Medical Officer of Health

Kingston, Frontenac and Lennox & Addington Public Health

Kingston, Ontario, Canada

Healthcare Infection Control Practices Advisory Committee (HICPAC)

Vacant

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Infectious Diseases Society of America (IDSA)

NEUZIL, Kathleen M., MD, MPH, FIDSA

Vaccine Development Global Program (PATH)

Clinical Professor 

Departments of Medicine and Global Health

University of Washington School of Medicine 

Seattle, WA

Infectious Diseases Society of America (IDSA) (alternate)

BAKER, Carol J., MD

Professor of Pediatrics

Molecular Virology and Microbiology

Baylor College of Medicine

Houston, TX

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD

Medical Director, Epidemiology

Orange County Health Care Agency

Santa Ana, CA

National Association of Pediatric Nurse Practitioners (NAPNAP)

STINCHFIELD, Patricia A., RN, MS, CPNP

Director

Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota

St. Paul, MN

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD

Chairman, Department of Preventive Medicine

Vanderbilt University School of Medicine

Nashville, TN

National Immunization Council and Child Health Program, Mexico

VILLASEÑOR RUIZ, Ignacio

Directora del Programa de Atencion da la Salud de la Infancia y la Adolescencia / Director 

General, Child and Adolescent Health

Centro Nacional Para la Salud de la Infancia Y La Adolescencia / National Center for Child and 

Adolescent Health

Ministry of Health / Secretaría de Salud

Mexico 

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National Medical Association (NMA)

WHITLEY-WILLIAMS, Patricia, MD

Professor and Chair

University of Medicine and Dentistry of New Jersey

Robert Wood Johnson Medical School 

New Brunswick, NJ

National Vaccine Advisory Committee (NVAC)

ORENSTEIN, Walt, MD

Chair, NVAC 

Associate Director, Emory Vaccine Center

Emory University

Atlanta, GA

Pediatric Infectious Diseases Society (PIDS)

SAWYER, Mark H, MD

Professor of Clinical Pediatrics

University of California, San Diego School of Medicine

San Diego, CA

Pediatric Infectious Diseases Society (PIDS) (alternate)

ENGLUND, Janet A., MD 

Professor, Department of Pediatrics

Seattle Children's Hospital

University of Washington

Seattle, WA

Pharmaceutical Research and Manufacturers of America (PhRMA)

BRAGA, Damian A.

President, Sanofi Pasteur

Swiftwater, PA

Society for Adolescent Health and Medicine (SAHM)

MIDDLEMAN, Amy B., MD, MSEd, MPH

Professor of Pediatrics

Chief, Section of Adolescent Medicine

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Society for Healthcare Epidemiology of America (SHEA)

WEBER, David, MD, MPH

Professor of Medicine, Pediatrics, and Epidemiology

University of North Carolina Schools of Medicine and Public Health

Medical Director, Hospital Epidemiology and Occupational Health, UNC Health Care

University of North Carolina

Chapel Hill, NC

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